Multiple Myeloma study: Ramantamig vs Tocilizumab
Official title A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07589634
What this study is testing
What is Ramantamig?
Ramantamig is an investigational subcutaneous injection being studied for multiple myeloma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether giving tocilizumab before ramantamig can prevent or lessen the severity of cytokine release syndrome (CRS) within 28 days of treatment, compared with a placebo.
- Who it's for
- It is looking for adults who have relapsed or refractory multiple myeloma and are scheduled to receive ramantamig.
- What's involved
- Participants will receive either tocilizumab or a placebo before starting ramantamig. They will be monitored for CRS symptoms and other health measures during the study period.
- Time commitment
- The study lasts 28 days after ramantamig starts, with regular visits and tests to check for CRS and other health changes.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented diagnosis of multiple myeloma (MM) as defined by the criteria: a.
- Received at least 1 prior lines of antimyeloma therapy
- Relapsed or refractory disease as defined: a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed...
- Have an eastern cooperative oncology group (ECOG) performance status (PS) score of 0 to 2 at screening and immediately before the start of study...
- Have clinical laboratory values meeting the criteria specified in the protocol
You likely can't join if
- Concurrent use of any other anticancer treatment (including non-palliative radiotherapy) or investigational agent
- Major surgery, (for example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has...
- Suspected or known allergies, hypersensitivity, or intolerance to ramantamig and tocilizumab or their excipients
- Presence of any of the following: a. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); b.
- Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM.
The study team makes the final eligibility decision.
Where it is enrolling
- Goodyear, Arizona, United States
- Beverly Hills, California, United States
- Irvine, California, United States
- Palo Alto, California, United States
- Denver, Colorado, United States
- St Louis, Missouri, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Salt Lake City, Utah, United States
- Buenos Aires, Argentina
- Córdoba, Argentina
- Pilar, Argentina
- Bedford Park, Australia
- Birtinya, Australia
- Concord, Australia
- Fitzroy, Australia
- Wollongong, Australia
- Argenteuil, France
- Bayonne, France
- La Tronche, France
+ 31 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Goodyear, Arizona, United States; Beverly Hills, California, United States; Irvine, California, United States; Palo Alto, California, United States; Denver, Colorado, United States; St Louis, Missouri, United States and 45 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.